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POLMIL (PSM6000 USG Probe Latex Cover, powdered)
EUDAMEDClass I (EU MDR)
Ref ELT-085Model Probe Cover
Identity
- Trade Name
- POLMIL (PSM6000 USG Probe Latex Cover, powdered) EUDAMED
- Device Name
- Latex Probe Cover EUDAMED
- Model / Reference
- Probe Cover EUDAMEDELT-085 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05902406208590 EUDAMED
- Basic UDI-DI
- 955410035270PROBECOVERWT EUDAMED
- Direct Marketing DI
- 05902406208590 EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
POLMIL (PSM6000 USG Probe Latex Cover, powdered) by Eurolatex Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 955410035270PROBECOVERWT | Class I | Active |
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Manufacturer
- Manufacturer
- Eurolatex Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000003748
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 14399088-d996-4c06-b5c4-d4d28a7b7257 61 fields · synced Jun 19, 2026